Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Reported: October 14, 2015 Initiated: July 27, 2015 #D-0008-2016
Product Description
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
Reason for Recall
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Details
- Recalling Firm
- Noven Pharmaceuticals, Inc.
- Units Affected
- 125,250 Patches
- Distribution
- US Nationwide
- Location
- Miami, FL
Frequently Asked Questions
What product was recalled? ▼
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3. Recalled by Noven Pharmaceuticals, Inc.. Units affected: 125,250 Patches.
Why was this product recalled? ▼
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 14, 2015. Severity: Moderate. Recall number: D-0008-2016.
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